Sop for Sanitization of Hot Sanitization & Electro Deionization unit
1.0 Objective
To lay down a procedure for Sanitization of Hot Sanitization Reverse Osmosis & Electro Deionization Unit.
2.0 Scope
This Standard Operating Procedure is applicable for Sanitization of Hot Sanitization Reverse Osmosis & Electro Deionization Unit to be followed at formulation plants
3.0 Responsibility
3.1 Engineering Officer / Executive shall be responsible for the execution of this procedure.
3.2 Engineering Manager shall be responsible for the implementation of this SOP.
3.3 Head QA/designee shall be responsible for the compliance of this SOP.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure etc
QA : Quality assurance
PW : Purified Water
KL : Kilo liter
ER : Engineering
HSRO : Hot Sanitization Reverse Osmosis
EDI : Electro Deionization Unit
RO-1 : Reverse Osmosis-1
5.0 Procedure
5.1 Ensure that there is not production.
5.2 Use necessary safety wears, while doing the work.
5.3 Check the level of water in Multi Purpose Water Tank. It should be between 250 to 300 Lit.
If the level is less generate the water by RO-1. Open inlet/outlet valves and start the pump
by SCADA.
5.4 Open the steam inlet valve and Start heating in the Multipurpose water tank so that return
water temperature reaches a limit of 80-85 Deg.
5.5 Circulate the water for 1 hour and stop the pump and Hold it for 3-4 Hours to cool it
slowly.
5.6 Drain off the water by opening dump valve and individual drain points of Sanitization of
Record Hot Sanitization Reverse Osmosis & Electro Deionization Unit as well as tank
and fill the RO-1 Product water in the tank.
5.7 Sanitization is to be carried out with frequency of 30±5 days or as and when quality of
water Crosses action level.
5.8 Sanitization record is maintained as shown in Annexure – 1.
6.0 Forms and Records
6.1 Sanitization Record for Hot Sanitization Reverse Osmosis&
Electro Deionization Unit – Annexure-1
7.0 Distribution
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Controlled copies – Engineering Department
sop for Execution of Preventive Maintenance
Preparation of Sodium Hydroxide Solution
sop for water cooled chiller operation
cleaning and preventive maintenance of LAF and RLAF
sop for replacement of water system filters
cleaning and preventive maintenance of insectocutor
sop for operation of preventive maintenance
sop for material receiving and consumption record
sop for Preventive maintenance of bottle washing machine
sop for Replacement of Battery of Electronic Devices
sop for Preparation of R.O. Antiscalant Solution
Preventive Maintenance of Rapid Cooling Steam Sterilizer
Preventive Maintenance of Rapid cooling steam Generator
sop for Preventive Maintenance of Dust Collector
sop for Replacement of HVAC filters
SOP for Battery Backup in Mobile Laminar Air Flow Trolley
sop for Replacement of Tube lights
sop for Replacement of UV light of purified water plant
sop for Cleaning of soft water storage tank and RO feed tank
sop for Preparation of Sodium hydroxide Solution
sop for Operation and regeneration of softener plant
Procedure Of Issuance Of material from Engineering Store
sop for Preventive Maintenance of Filter Press
sop for Preventive Maintenance of Sugar Transfer System
sop for Preventive Maintenance of Shrink Sleeve Machine
sop for Preventive Maintenance of ROPP Cap Elevator
sop for Preventive Maintenance of Liquid Transfer Pumps
sop for Preventive Maintenance of Liquid Tanks
Preventive Maintenance of Strip De-Foiling Machine
sop for Preventive Maintenance of Colloidal Mill
sop for Preventive Maintenance of Packing Collator Belt
sop for Checking light intensity
sop for Operation of Fire- Extinguisher
sop for Passivation of WFI Distribution Loop
sop for Analysis of Effluent Treatment Plant Water
sop for Methodology to Dispose ETP Sludge
sop for Action Plan In Case Of Electrical Power Failure
sop for Colour Coding of Piping and Accessories of Utilities
sop for Disposal of Engineering Waste
Filter Cleaning of HVAC System RLAF & LAF
Procedure for Calibration of Magnehelic Gauge
Procedure for Calibration of Vacuum Gauge
Procedure for Calibration of Pressure Gauge
sop for Procedure for Calibration of Temperature Controller
sop for Preventive Maintenance of Infrared Dryer Umbrella Type
sop for Preventive Maintenance of Battery stacker
sop for Preventive Maintenance of Lift
sop for Preventive Maintenance of Vacuum Cleaner
sop for Preventive Maintenance of laminar air flow unit
sop for Preventive Maintenance of Lozenges Manufacturing Line
sop for Preventive Maintenance of Garment Washing Machine
sop for Preventive Maintenance of Multi Column Distillation Plant
sop for Preventive Maintenance of Steam Sterilizer Autoclave
sop for Preventive Maintenance of Pure steam Generator
sop for Preventive maintenance of Depyrogenating Tunnel
sop for Preventive Maintenance of vial sealing machine
sop for preventive maintenance of Powder Filling and Rubber Stoppering machine
sop for Preventive Maintenance of Vial Washing Machine
sop for Preventive Maintenance of Inspection Table
sop for Preventive Maintenance of Hi-Cart
sop for Preventive Maintenance of Turn table
sop for Preventive Maintenance of sticker labeling machine
sop for Preventive Maintenance of Liquid Filling and Sealing Machine
sop for Preventive Maintenance of Linear Bottle Washing Machine
sop for Preventive Maintenance of De-Foiling Machine
sop for Preventive Maintenance of Strip Packing Machine
sop for Preventive Maintenance of Blister Packing Machine
sop for Preventive Maintenance of Capsule Polishing and Sorting Machine
sop for Preventive Maintenance of Capsule Filling Machine
sop for Preventive maintenance of Auto Coater
sop for Preventive Maintenance of Compression Machine
sop for preventive maintenance of packing conveyor belt
sop for Preventive Maintenance of Sifter Cum Multi mill
sop for Preventive Maintenance of Rapid Mixer Granulator
sop for Preventive Maintenance Of Fluid Bed Dryer
sop for Preventive Maintenance of Octagonal Blender
sop for Preventive Maintenance of Lifting and Positioning Device
sop for Preventive Maintenance of Paste Preparation vessel
sop for preventive maintenance of Vibro-Sifter
sop for preventive maintenance of air curtain
sop for preventive maintenance of air handling units
Preventive Maintenance of Diesel Generator
sop for Preventive Maintenance of cooling towers
sop for Preventive Maintenance of Boiler
sop for Preventive Maintenance of Air Compressor
sop for Preventive Maintenance of Chilling Plant
sop for Preventive Maintenance of Transformers
sop for Preventive maintenance of Purified Water System
sop for Break Down maintenance of Machine and Work Requisition
sop for Operation of Dust Extraction System
sop for Operation Of Effluent Treatment Plant
sop for Operation Of Diesel Generator
sop for Operation of Multi Column Distillation Plant
sop for Operation of Pure Steam Generator
sop for Operation of Air Handling Unit
sop for Operation of Cooling Tower
sop for Operation of Air Compressor
sop for Operation of Water Chilling Plant
sop for Cleaning of Pure Steam Generator
Cleaning of Over Head Water Tanks HDPE
sop for Cleaning of Water tanks
sop for Sanitization of multi column plant
sop for Sanitization of Ultrafiltration System
Sop for Chemical Sanitization of Reverse Osmosis
Sop for Sanitization of Hot Sanitization & Electro Deionization unit
sop for Sanitization of Purified Water Loop
sop for preparation of sodium meta bisulphate solution
sop for Testing of Hardness of Soft Water